Sterility Assurance Manager
3 ore fa
At Thermo Fisher Scientific team, you'll discover impactful job, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind.
The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our products are safe.
As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions.
Our dedication to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building an exciting career with us.
**Ferentino, Italy | Quality**:
**Discover Impactful Work**:
The resource will be part of a very stimulate environment and will ensure that the production processes for the manufacturing of sterile injectable drugs are conducted with robustness and in compliance with the appropriate standards of Sterility Assurance, the current GMP regulations, the internal procedures and Corporate Standards.
The role will:
- Lead the definition and implementation of appropriate contamination control strategies (CCS) and he will assure their lifecycle management.
- Define the strategy for Aseptic Process Simulation validation/revalidation activities, approving the APS program and defining the site EM monitoring program and its effectiveness.
- Lead and provide support in the evaluation of investigations that impact the aseptic techniques and actively participating in the identification of corrective/preventive actions.
- Receive constant training on GMP in the field of Sterility Assurance and transfer this training to the site SMEs.
- Act as SME during regulatory and customer audits and new project introduction.
- Represent the Site in the Corporate Sterile Working Group meetings by harmonizing the practices/procedures/processes between the various sites of the network.
- Promote the continuous improvement in aseptic technique culture/behavior and he will implements PPI projects within SA team.
- Coordinate and support team members with training, feedback and mentor and draws up, together with the HR business partner, appropriate plans for the development of resources, promoting the job rotation of talents.
**Keys to Success**:
**Education**:
- Minimum Bachelor's degree required.
Chemical, Scientific/Technical field such us Biology/Biotechnology, Chemistry, and Pharmacy.
**Experience**:
- Proven experience in similar positions within a regulated environment such as pharmaceutical or biotech companies (Sterility assurance Senior manager, Microlab Manager, MS&T Manager, MSAT Manager, Process Engineering Manager)
**Knowledge, Skills, Abilities**:
- Strong knowledge of global cGMP
- Thorough understanding of pharmaceutical laws (EU/US), and quality management system
- Experience in quality event management
- Manufacturing and validation experience
- Microbiologic Knowledge in sterile manufacturing site
- Strong knowledge of environmental monitoring/program (viable and total particles)
- Experienced people management
- Strong Communication skills
- Strong understanding of the manufacturing processes and aseptic validation
**Personality traits**:
- Leadership
- Marked Problem solving
- Decision Making
- Excellent communication & negotiation skills
**Languages**:
- English (Excellent)
**Technical skills**:
- GMP regulation (EU and US);
- Specific knowledge of Sterile injectable drugs production processes
- Sourced from Pharma FDA-approved companies;
- Broad and sound experience with Pharmaceutical Quality Systems (e.g Trackwise) and reporting tools.
Based on proven experience and qualifications we are open to evaluating any potential role upgrade.
This is an equal opportunity employer: here in Thermo Fisher celebrates diversity and it is committed to crafting an inclusive environment for all employees
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